Translational Pathways for Cardiovascular Devices – Session III: The Methods for Translational Mitral/Tricuspid Valve Device Development Practice Quiz – ISCTR | International Society for Cardiovascular Translational Research

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Question 1 of 7

1. Question
Which of the following is correct regarding surgery for mitral regurgitation in the US?
- Annual mitral valve surgery is performed on approximately 35,000 patients
- Annual mitral valve surgery is performed on approximately 55,000 patients
- Annual mitral valve surgery is performed on approximately 75,000 patients
- Annual mitral valve surgery is performed on approximately 100,000 patients
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Question 2 of 7

2. Question
Which of the following is correct regarding tricuspid regurgitation in the US?
- Tricuspid valve surgery procedures are performed on approximately 5,000 patients per year, however 15% is isolated surgery
- Tricuspid valve surgery procedures are performed on approximately 5,000 patients per year, however 30% is isolated surgery
- Tricuspid valve surgery procedures are performed on approximately 5,000 patients per year, however 45% is isolated surgery
- Tricuspid valve surgery procedures are performed on approximately 5,000 patients per year, however 60% is isolated surgery
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Question 3 of 7

3. Question
All of the following preclinical testing is required for mitral valve repair devices before they are introduced to humans, except:
- Stress analysis and fatigue testing
- Performance, safety and efficacy
- Device corrosion and crimping damage
- Valve durability
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Question 4 of 7

4. Question
Early feasibility studies in the US enable which of the following?
- Earlier access for new medical devices for US patients and investigators
- Familiarization of US regulators with devices earlier
- Preparation of clinical sites with device procedure before pivotal trials
- All of the Above
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Question 5 of 7

5. Question
The pivotal trial should satisfy all regulatory requirements and prove that the device is safe and effective
- True
- False
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Question 6 of 7

6. Question
Which of the following must the pivotal trial (randomized clinical trial) prove so the device can be approved by regulatory and reimbursed:
- The device is safe, effective and reasonable
- The device is safe, effective and cost effective
- The device is necessary, safe and effective
- The device is safe, effective, reasonable and necessary
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Question 7 of 7

7. Question
Which of the following is sufficient regarding clinical adoption?
- Device demonstrates improved outcome and received FDA approval
- Device demonstrates improved outcomes and is cost effective
- Device is FDA approved, and reimbursed
- Device is easy to use
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